Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma
|ClinicalTrials.gov Identifier: NCT00144976|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment|
|Head and Neck Neoplasms||Drug: Tarceva|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study, Without Direct Individual Benefice, of Biological Effect of Tarceva (OSI-774) at Posology of 150 mg by Day for Patients Stricken by ENT Epidermoid Carcinoma Waiting for First Surgical Picking up.|
|Study Start Date :||October 2003|
|Primary Completion Date :||December 2006|
|Study Completion Date :||December 2006|
- To evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.
- Correlation study between pharmacokinetic and biological effect observed of molecule OSI-774.
- Verification of biological effect of Tarceva's homogeneity (inhibition of EGFR-TK) according to sites, particularly from the point of view of a possible difference primary tumor/metastatic adenopathy and tumorous tissue/healthy tissue.
- Characterisation of OSI-774 modes of action from the cellular cycle arrest proteinic effectors's point of view.
- Constitution of frozen tissue bank for genomic (sequencing) study of tumorous EGF-R structure and for modification of in situ gene expression induction with OSI-774 by RNA microarrays technology.
- Pharmacogenomics study of Tarceva's metabolism : genes studied code for cytochrome 3A5 and glycoprotein-P.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144976
|Center Oscar Lambret|
|Institut claudius regaud|
|Principal Investigator:||Jean Pierre Delord, Docteur||Institut Claudius Regaud|